Movement Alert｜Hengrui Medicine Falls 3.05% in Regular Trading, FDA Issues Third Complete Response Letter for PD-1 Combination Therapy

Market Focus07-14

On July 14, Hengrui Medicine fell 3.05% in regular trading, trading at 58.8 HKD/share, with turnover of approximately 30.76 million HKD. The decline reflects continued pressure from the FDA's third rejection of the company's Biologics License Application for camrelizumab combined with apatinib for first-line treatment of unresectable or metastatic hepatocellular carcinoma.

The Complete Response Letter (CRL), disclosed on July 10, marks the third time this application has been blocked at the FDA review stage. The company stated that the CRL did not raise concerns about clinical data, safety, or efficacy, but rather centered on cGMP manufacturing site inspection observations related to the apatinib production facility, which underwent FDA inspection in April. Notably, the same facility passed European regulatory inspection in 2025. Hengrui said it is actively formulating corrective measures and communicating with FDA and partner Elevar Therapeutics to clarify subsequent filing plans.

(The above content is based on publicly available market information, generated by a program or algorithm, and is intended solely as a stock movement alert. It does not constitute investment advice or a basis for trading decisions.)

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